Recall Z-0708-03 ยท MNV Strip, Dialysate Ph Indicator
Deroyal Surgical -Rose Hill
DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless steel staples in peel away pouch. Pouch is labeled in part, ***sterile, disposable, do not resterilize***. Pouches are packaged 12 per box.
| Date | Apr 3, 2003 (initiated Feb 25, 2003) |
| Status | Terminated |
| Reason | Non-sterile surgical medical device is labeled as sterile product. |
| Root cause | Other |
| Action | Recalling firm notified consignees by certified mail 2/25/03 and advised to immediately cease using or distributing product. Distributors were requested to further notify their consignees or provide customer contacts. Consignees requested to return response form for replacement product. |
| Quantity | 216 units |
| Distribution | Product was sold to distributors and direct accounts in PA, TX, WA, AR, HI, CA and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.